NCT01138631

Brief Summary

In order to improve success rate by assisted reproductive techniques new techniques are being developed for selection of the embryo with best chance of implantation, establishement of pregnancy and subsequent delivery.The present study is based upon the hypothesis that time-lapse (frequent imaging) may give information about important steps in embryonic development, which could help to optimize selection of embryo(s) for treatment in IVF. The present study evaluates the outcome of conventional embryo culture with culture in a specially developed incubator equipped with a time-lapse system (Embryoscope). Embryos from 50 IVF cycles (400 embryos) will be randomised to either conventional incubation or to culture in the Embryoscope. Embryos will be cultured for five days to the blastocyst stage. The primary endpoint is fraction of embryos developed to the four cell stage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 31, 2017

Status Verified

May 1, 2011

Enrollment Period

6 months

First QC Date

June 4, 2010

Last Update Submit

March 30, 2017

Conditions

Infertility

Keywords

IVF, Infertility, embryo selection, embryoscope, time-lapse

Outcome Measures

Primary Outcomes (1)

  • 4-cell rate

    2 days after oocyte pick-up

Study Arms (2)

Embryoscope

ACTIVE COMPARATOR
Device: Embryoscope

Conventional incubator

NO INTERVENTION

Interventions

EmbryoscopeDEVICE

The embryoscope is an incubator with in-built photographic equipment

Embryoscope

Eligibility Criteria

AgeUp to 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients undergoing 2.nd or 3.rd IVF cycle with expected retrieval of 8 oocytes or more. Age \< 38 years

You may not qualify if:

  • Endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic, Aarhus University Hospital, Skejby

Aarhus, Aarhus, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Jakob Ingerslev, DMSc

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

March 31, 2017

Record last verified: 2011-05

Locations

DK(1)